December 2015

FDA awards stem cell co Pluristem orphan drug statusThe Israeli company received FDA orphan drug status for its PLX-PAD cells preeclampsia pregnancy treatment.
 
Japan Pins Hopes On Israeli Stem-Cell TechFour years after Japan’s Fukushima nuclear plant disaster, Fukushima Medical University’s Global Medical Science Center has signed a memorandum of understanding with Israel’s Pluristem Therapeutics to collaborate on further development of the company’s placenta-based cell therapy products to treat acute radiation syndrome (ARS) and morbidities following radiotherapy in cancer patients.
 
Israeli breakthrough drug helped cure Jimmy Carter’s cancerIsraeli-tested drug that tackles cancer through sophisticated manipulations of the body’s natural immune system was key in helping rid former US president Jimmy Carter of life-threatening tumors that developed after he was diagnosed with melanoma earlier this year. Researched in Israel by Professor Jacob Schachter of the Ella Institute for melanoma treatment and research at the Sheba Medical Center in Tel Hashomer, Keytruda is part of a promising new class of drugs called immunotherapies, which harness the body’s immune system to help fight cancer.
 
The LSIE 2015 events for life sciences industry  held on December 9th 2015 at the David Intercontinental Hotel in Tel Aviv. As part of the event, two leading professional conferences: MDDMI- 6th Annual Conference for the development and manufacture of medical devices in Israel lasts two days and CT conference on the subject of clinical research and regulatory Israel. The event combines a conference and professional exhibition sponsored by the Ministry of Economy, the company OrbiMed and I.M.P. (Hebrew)
 
Israeli Oramed inks huge $50m deal with Chinese pharma firm. In one of the biggest deals so far between Israel and China – and one of the biggest in the Israeli medical technology industry – Israeli pharma firm Oramed on Monday signed a licensing and investment deal with China’sHefei Life Science & Technology Park Investments and Development Co. (HLST), a subsidiary of Chinese pharma giant Sinopharm, for the rights to its oral insulin capsule.
 
The FDA and the Office for Human Research Protections (OHRP) are extending the comment period for the joint draft guidance entitled “Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs.” The Agencies are taking the initiative to extend the comment period for an additional 30 days because the timing of the due date for comments intersects with comment periods on other Federal Register documents requiring review by the same group of stakeholders. This extension will allow interested persons additional time to submit comments. This joint draft guidance is available on FDA's website at http://www.fda.gov/RegulatoryInformation/Guidances/ucm470046.htm, and OHRP’s website at http://www.hhs.gov/ohrp/newsroom/rfc/index.html.
 Comments are due by February 3, 2016.
 
3M expands Israel operations with first customer innovation center. The 3M company launched a customer innovation center in Herzliya, a move that signals its interest in Israel as a market, and not simply a source of technology.
 
Israel Biotech Fund to raise $50-100m.  Investors in the new fund include Dr. Yuval Cabilly and Nasdaq-traded Biogen. Dr. Yuval Cabilly is founding a new venture capital fund, the Israel Biotech Fund, which will attempt to raise $50-100 million. The fund is intended to focus on biotech companies.
 
Save the date: Ctrials Annual Meeting will be held on April 11th 2016 at the David Intercontinental Tel Aviv. Ctrails is the Israeli Association for the advancement of the biomedical research community.
                       
Now live! Our new translations division of high quality certified medical and pharmaceutical translations. You are welcome to visit our new webpage: www.qt-translations.com